Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05574244
Other study ID # CHUBX 2019/57
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 29, 2022
Est. completion date April 15, 2027

Study information

Verified date June 2023
Source University Hospital, Bordeaux
Contact Grégoire ROBERT
Phone 05.57.82.06.87
Email gregoire.robert@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

It has been demonstrated that sexual activity was common in the majority of men over 50 years old and was an important component of overall quality of life (QoL). Ejaculatory dysfunction (EjD) is the most common side effect of surgical treatment of benign prostatic obstruction (BPO). It has been considered for decades to be an inevitable consequence of restoring micturition comfort. EjD can have a substantial deleterious effect on the QoL of men with previously maintained regular sexual activity, inducing decreased orgasmic intensity and increased levels of anxiety and depression. A better understanding of the physiology of ejaculation has enabled the emergence of modified surgical techniques that aim to preserve antegrade ejaculation. Our hypothesis is that conservation of ejaculation can be achieved by modified surgical procedures without compromising functional outcomes.


Description:

The aim of this study is To compare the efficacy of partial trans urethral resection of the prostate versus conventional resection of the prostate in improvement of lower urinary tract symptoms related to benign prostatic hyperplasia at 6 months. The secondary objectives are to compare the impacts of partial prostatic endoscopic surgery versus conventional endoscopic surgery on ejaculatory function, lower urinary tract symptoms, Global sexual life, Urinary flow, complication related to the surgery and the rates of re-treatment. Investigators use a non-inferiority comparative single blinded (patient) multicenter randomized clinical trial in two parallel groups (Conventional endoscopic prostatic surgery Vs Partial surgery preserving the prostatic apex.


Recruitment information / eligibility

Status Recruiting
Enrollment 336
Est. completion date April 15, 2027
Est. primary completion date March 29, 2024
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility Inclusion Criteria: - Man over 40 years old - Indication of surgical management for BPH - Prostate volume =30 cc and =100 cc as evaluated by ultrasonography - IPSS score =12 - Qmax =15 ml/s - Affiliated to French national social security system - wish and be able to comply with planned visits - Able to express his consent - Signed informed consent form Exclusion Criteria: - Unwillingness to accept the treatment - No pre-operative ejaculation or sexuality - Neurological pathology responsible for micturition disorders - History of prostatic surgery - History of prostatic arterial embolisation - Stenosis of the urethra - History of prostate cancer - History of radiotherapy or pelvic surgery - Patient refusing the principle of partial surgery - Life expectancy <3 years - Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks. - Participation in another clinical study involving an investigational product within 1 month before study entry.

Study Design


Intervention

Procedure:
Partial surgery preserving the prostatic apex
Partial Endoscopic resection of prostate to conserve apex
Conventional endoscopic prostatic surgery
Endoscopic resection of prostate.

Locations

Country Name City State
France CH Pays d'Aix Aix-en-Provence
France CHU Angers Angers
France Centre Hospitalier Universitaire de Bordeaux Bordeaux
France CHU Mondor Créteil
France Hôpital Claude Huriez Lille
France CHU de Limoges Limoges
France Polyclinique Saint George Nice
France Hôpital cochin Paris
France Hôpital Tenon Paris
France Hôpital Prive Francheville Périgueux
France Hôpital Lyon Sud HCl Bât.3C Centre Hospitalier Lyon Sud Pierre-Bénite
France Hôpital Privé des Côtes D'Armor Plérin
France Clinique Pasteur Toulouse
France CHRU Hôpitaux de tours Tours
France Hopital Privé de Versailles, Clinique des Franciscaines Versailles

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of IPSS (International Prostatic Symptom Score) score at 6 months the mean IPSS score measured at 6 months, to compare the efficacy of partial endoscopic resection versus complete endoscopic resection in improvement of lower urinary tract symptoms related to BPH. IPSS scores are categorised as 'asymptomatic' (0 points), 'mildly symptomatic' (1-7 points), 'moderately symptomatic' (8-19 points), and 'severely symptomatic' (20-35 points). 6 months after surgery
Secondary Evaluation of ejaculation and global sexual life MSHQ ejd= Male Sexual Health Questionnaire for Ejaculatory Dysfonction Scale score : [1-20] : a higher score mean that the subject have a ejaculatory dysfunction and sexual troubles 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of lower urinary tract symptoms Urinary Symptom Profile (USP) :
1a+1b+1C [0-9]. A higher score mean that the subject have urinary leakage
2+3+4+4bis+5+6+7 [0-21]. A higher score mean that the subject have voiding urgency
8+9+10 [0-9]. A higher score mean that the subject have voiding problem
1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of complication rates Complications based on Clavien Dindo classification 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of ejaculation and global sexual life IIEF-15 (including orgasmic function: questions 9 and 10), auto-questionnaire (superiority test) 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of ejaculation and global sexual life DAN PPS-SEX= Danish Prostatic Symptom Score -Sexual Questions 1A And B are question about erectyl function Questions 2A, 2B, 3A and 3B are questions about ejaculatory function Questions 4A is a question about global sexual quality of life 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of lower urinary tract symptoms IPSS = International Prostate Score Symptom Scale score [0-35]. The higher score mean that the subject have important lower urinary tract symptoms. 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of lower urinary tract symptoms Qmax (non-inferiority test) not performed at 1 month 1 month, 3 months, 6 months,12 months, and 36 months after surgery
Secondary Evaluation of complication rates Re-intervention rate 1 month, 3 months, 6 months,12 months, and 36 months after surgery
See also
  Status Clinical Trial Phase
Recruiting NCT04807296 - Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP) N/A
Recruiting NCT04288427 - 5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy N/A
Not yet recruiting NCT04245566 - Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH Phase 3
Completed NCT03246880 - Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients Phase 3
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Completed NCT02509975 - Safety and Efficacy of OCL 503 in Prostate Artery Embolization N/A
Completed NCT02283684 - GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT Phase 4
Completed NCT02206243 - Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
Completed NCT01454349 - Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH) Phase 1/Phase 2
Completed NCT01438775 - Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) Phase 3
Completed NCT01152190 - A Study in Benign Prostatic Hyperplasia Phase 3
Completed NCT01139762 - A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms Phase 3
Active, not recruiting NCT00400894 - Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma N/A
Completed NCT00701779 - Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia Phase 4
Completed NCT00224133 - The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months Phase 3
Unknown status NCT00381108 - Study of the Effects of Pomegranate Tablets on Enlarged Prostates Phase 1
Terminated NCT02962674 - To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. N/A
Active, not recruiting NCT05415748 - Deprescribing Tamsulosin in Older Men Phase 4
Recruiting NCT04853914 - Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound. N/A
Completed NCT04831476 - Α Prospective Observational Study for the Evaluation of Disease Control and Quality of Life in Patients With Benign PROStatic hyPERplasia Under Fixed Dose combΙnaTion Treatment With Dutasteride and Tamsulosin . PROSPERITY Group of Studies (I&II)